C8000 CALCIUM

Additional Manufacturer Narrative

PT SAMPLE WAS DISCARDED BY THE ACCOUNT AND IS UNAVAILABLE FOR RETURN. NO INSTRUMENT CAUSES FOR THE ERRONEOUS CALCIUM RESULT ARE APPARENT. NO REAGENT CAUSE FOR THE ERRONEOUS RESULT IS APPARENT. THE QC WAS STABLE WITH NO APPARENT TRENDS OR SHIFTS IN CALCIUM RECOVERY. OTHER RESULTS GENERATED BY THE SYS ARE ACCURATE INCLUDING SEVERAL PANIC VALVES THAT WERE RECHECKED AND VERIFIED. THE CUSTOMER SUSPECTS FIBRIN WAS RESPONSIBLE, AS THERE WAS NO MANUAL CHECK FOR IT PRIOR TO ASSAYING THE SAMPLE. THE INSTRUMENT AND REAGENT DOCUMENTATION ADVISE THE CUSTOMER THAT FIBRIN, BUBBLES OR PARTICULATE MATTER MAY INTERFERE WITH THE ASSAY AND CAUSE ERRONEOUS RESULTS. FIBRIN MAY PREVENT AN ADEQUATE AMOUNT OF SAMPLE FROM BEING ASPIRATED OR DISPENSED INTO THE CUVETTE. IN ADDITION, THE INSTRUMENT LOGS HAVE BEEN REQUESTED FROM THE CUSTOMER. AN EXAMINATION OF THESE LOGS WILL BE PERFORMED BEFORE ANY FINAL CONCLUSIONS ARE DRAWN. A FINAL REPORT WILL BE SUBMITTED AT THE COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER STATED THAT THE ARCHITECT C8000 GENERATED A LOW CALCIUM RESULT OF 2.8 MG/DL WITH REAGENT LOT # 13053HW00. THE SAMPLE WAS REPEATED TWO TIMES WITH RESULTS OF 7.4 MG/DL. THE CUSTOMER STATED THAT THEY DID NOT CHECK THE SAMPLE FOR FIBRIN PRIOR TO RUNNING IT THE FIRST TIME, BUT STATED NO FIBRIN WAS PRESENT AFTER THE INITIAL RUN. THE CUSTOMER STATED THAT THEY HAD NO OTHER INSTANCES OF ERRATIC RESULTS. THE CUSTOMER FELT THE ISSUE WAS DUE TO FIBRIN IN THE SAMPLE AND HAVE ASKED THEIR TECHS TO MONITOR THE SAMPLES CLOSELY FOR FIBRIN. THERE WAS NO IMPACT TO PT MGMT AS THE RESULT WAS NOT REPORTED.